- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00458666
Coagulation Parameters During Pregnancy in Amniotic Fluid
April 10, 2007 updated by: Rambam Health Care Campus
Amniotic fluid embolism is a rare devastating thromboembolic event, which is probably caused by the entrance of amniotic fluid (AF) to the maternal circulation.
While AF contains coagulation activators, their role during pregnancy has not been elucidated.
The current study aimed to evaluate coagulation parameters in AF during human pregnancy.
Study Overview
Status
Unknown
Conditions
Detailed Description
Amniotic fluid embolism is a rare devastating thromboembolic event, which is probably caused by the entrance of amniotic fluid (AF) to the maternal circulation.
While AF contains coagulation activators, their role during pregnancy has not been elucidated.
The current study aimed to evaluate coagulation parameters in AF during human pregnancy.
Study Type
Observational
Enrollment
170
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Haifa, Israel
- Recruiting
- Dept of Obstetrics and Gynecology, Rambam-Health Care Campus
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Contact:
- Arie Drugan, M.D
- Phone Number: +972-50-206-2006
- Email: a_drugan@rambam.health.gov.il
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Women undergoing amniocentesis during 15-35 weeks of gestation.
Exclusion Criteria:
- A history of venous thromboembolism
- Systemic disease i.e.; diabetes, hypertension, hypo or hyper-thyroidism,
- Anticoagulant treatment
- Abnormal embryo
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Benjamin Brenner, M.D, Rambam Health Care Campus
- Study Chair: Arie Drugan, M.D, Rambam Health Care Campus
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2006
Study Registration Dates
First Submitted
April 10, 2007
First Submitted That Met QC Criteria
April 10, 2007
First Posted (Estimate)
April 11, 2007
Study Record Updates
Last Update Posted (Estimate)
April 11, 2007
Last Update Submitted That Met QC Criteria
April 10, 2007
Last Verified
March 1, 2007
More Information
Terms related to this study
Other Study ID Numbers
- CoagulationAmnioticFluid_CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.